F10-F19
Conditions
Interventions
Group 1: After providing written informed consent, patients who meet the inclusion criteria will be enrolled upon admission to the inpatient addiction rehabilitation (withdrawal treatment) program. Th
if a leukocyte value from routine clinical diagnostics is already available at the respective time point, it is extracted from the medical record and no additional blood draw is performed. Each blood
Sponsors
Bezirksklinik Hochstadt, Gesundheitseinrichtungen des Bezirks Oberfranken (GeBO)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study population includes all patients who meet the inclusion criteria and are treated at the Bezirkskrankenhaus Hochstadt during the defined data collection period (planned as a one-year cohort). Eligible participants are adults who undergo inpatient withdrawal treatment for a substance-related disorder in the clinic and who are willing to provide written informed consent to participate in the study. The substance-related disorder according to ICD-10 must be either alcohol dependence (F10.2) or stimulant use disorder (F15.1/F15.2), provided that alcohol or amphetamine/methamphetamine represents the primary substance and the main reason for inpatient withdrawal treatment. For the alcohol group, inclusion requires a current diagnosis of F10.2, with alcohol being the primary substance and the main reason for inpatient withdrawal treatment. For the methamphetamine/amphetamine group, inclusion requires a current diagnosis of F15.1 and/or F15.2 within the stimulant category (F15), provided that methamphetamine/amphetamine is the primary substance and the main reason for inpatient treatment. Additional use or dependence on other substances is permitted, except for current alcohol dependence (F10.2). Patients with multiple substance use disorders (F19.1/F19.2) are excluded from both groups. Further prerequisites for participation are the ability to provide informed consent and a planned inpatient stay.
Exclusion criteria
Exclusion criteria: Patients with multiple substance use disorders (F19.1/F19.2), patients with a current alcohol dependence (F10.2) in the stimulant group, individuals who are unable to provide informed consent, and those who do not provide written consent to participate are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes include the assessment of the blood parameters cortisol, CRP and leukocytes as well as the evaluation of stress-coping strategies using the standardized SVF-120 questionnaire. Cortisol, CRP and leukocytes are measured at three time points: upon admission (T1.1, days 1–3), midway through the planned treatment duration (T2), and within the last three days prior to discharge (T3.1). The measurements are obtained via venous blood sampling performed in the morning under standardized conditions. Stress-coping strategies are assessed twice using the standardized SVF-120 questionnaire: within the first 14 days after admission (T1) and within the last 14 days before discharge (T3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the explorative analysis of potential subgroup differences with regard to psychiatric comorbidities. Classification is performed according to ICD-10 into five groups: (1) Intellectual disability, developmental disorders, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence (F70–F98), (2) Affective disorders (F30–F39), (3) Neurotic, stress-related, and somatoform disorders (F40–F48), (4) Schizophrenia, schizotypal and delusional disorders (F20–F29), and (5) Other or no additional psychiatric comorbidity besides the primary diagnosis of a substance-related disorder (F10.2 or F15.1/F15.2). Additional psychiatric diagnoses are assigned to groups (1)–(4) if applicable; otherwise, they are allocated to group (5). Multiple diagnoses are assigned hierarchically (priority: (4) ? (2) ? (3) ? (1) ? (5)), ensuring that each patient is assigned to exactly one main group. To ensure sufficient case numbers per category and to maintain statistical interpretability, further subdivision of groups is not performed. Somatic comorbidities are permissible and do not affect group allocation. In addition, anamnesis, demographic and clinical variables (including primary substance, previous treatment experience, family history of substance-related disorders, discharge type, and sociodemographic information) are collected. Each blood draw is accompanied by a brief anamnestic assessment of whether CRP may potentially be confounded by a somatic cause (based on the overall clinical impression; e.g., fever = 38.0°C, signs of infection or inflammation, injury/tissue damage, acute worsening of an underlying condition beyond what would be expected from the withdrawal process). Data collection is performed using a pseudonymised, study-specific assessment form with single-choice response options per variable, supplemented by numerical entries where applicable. | — |
Countries
Germany
Contacts
Public ContactThomas W. Kallert
Gesundheitseinrichtungen des Bezirks Oberfranken (GeBO)
Outcome results
None listed